Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2
Treatment lifestyle education sessions and youth exercise sessions
Sponsor Arizona State University
Collaborator National Institutes of Health (NIH)
Start date June 2010
End date December 2011
Trial size 60 participants
Trial identifier NCT01236794, P20MD002316ELSC

Summary

The purpose of this study is to examine the effects of a lifestyle intervention program on type 2 diabetes risk factors and quality of life in overweight Latino youth.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
lifestyle education sessions and youth exercise sessions ELSC
The intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.

Primary Outcomes

Measure
Insulin Sensitivity
time frame: About 12 Weeks

Secondary Outcomes

Measure
Quality of Life
time frame: About 12 Weeks

Eligibility Criteria

Male or female participants from 14 years up to 85 years old.

Inclusion Criteria: - Hispanic Ethnicity (Child and Parent) - Age 14-16 (Child) and Parent age < 85 - BMI Percentile above the 85th (child) - Ability to read and speak English (child) Exclusion Criteria: - Taking medication(s) or diagnosed with a condition that could influence exercise ability or carbohydrate metabolism (e.g., polycystic ovarian syndrome, exercise induced asthma, orthopedic limitations) (Child and (Parent OGTT only)) - Involved in any formal weight-loss program in the past 6 months (Child) - Diagnosed diabetes (type 1 or type 2 Child) - Weight is less than 110 Ibs (Child and Parent)

Additional Information

Official title Community-Based Participatory Research to Improve Health and Quality of Life of Latino Youth: Every Little Step Counts
Description With the increasing prevalence of obesity, the incidence of obesity-related co-morbidities including depression and type 2 diabetes have emerged as critical public health conditions. Furthermore, Latinos experience a disproportionately greater burden of these obesity-related disorders. Therefore, we have developed a 12-week community-based lifestyle intervention that includes weekly education sessions for children and their parents and 3 exercise sessions per week for youth. The program will be delivered at a local YMCA in the greater Phoenix Metropolitan area.
Trial information was received from ClinicalTrials.gov and was last updated in November 2010.
Information provided to ClinicalTrials.gov by Arizona State University.